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510(k) K014034

Device
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
Applicant
Beckman Coulter, Inc.
510(k) number
K014034
Product code
JFL
Decision
Substantially Equivalent (SESE)
Decision date
2001-12-18
Date received
2001-12-07
Regulation
862.1160
Classification name
Ph Rate Measurement, Carbon-Dioxide
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ANNETTE HELLIE
Address
200 S. Kraemer Blvd. W-110 Brea CA US 92822 92822

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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